BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1026928 · Received April 9, 2008

    Report

    Report Number
    2953144-2008-00293
    Event Type
    Malfunction
    Date Received
    April 9, 2008
    Date of Event
    February 25, 2008
    Report Date
    March 18, 2008
    Manufacturer
    ABBOTT VASCULAR REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT. DEVICE #1 PERCLOSE PROGLIDE, PART#2 12673-03, LOT#61137-6H, IS BEING FILED UNDER MEDWATCH MFR #2953144-2008-00291. DEVICE #2 PERCLOSE PROGLIDE, PART#3 12673-03, LOT#61137-6H, IS BEING FILED UNDER MEDWATCH MFR #2953144-2008-00292.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: DEVICE #3 CUFF MISS. TIME OF MALFUNCTION: DURING VESSEL CLOSURE. SYMPTOMS/AE: FAILURE TO ACHIEVE HEMOSTASIS. IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE FEMORAL ARTERY AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, THE PHYSICIAN EXPERIENCED A CUFF MISS WITH THREE SEPARATE PROGLIDE DEVICES. HEMOSTASIS WAS ACHIEVED WITH MANUAL COMPRESSION. THERE WERE NO ADVERSE PT EFFECTS. THOUGH REQUESTED, NO ADD'L INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM MGB ABBOTT VASCULAR REDWOOD CITY NA 61137-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 LOT # 61137-6H| DEVICE #1: PERCLOSE PROGLIDE 12673-03| LOT # 61137-6H| DEVICE #2: PERCLOSE PROGLIDE 12673-03